Trial · NCT01581840
Radiochemotherapy With Panitumumab in the Localised Epidermoid Carcinoma of the Anus
NCT01581840, Phase 1, Phase 2, Completed, Federation Francophone de Cancerologie Digestive; results first posted 2024-07-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Radiochemotherapy With Panitumumab in the Localised Epidermoid Carcinoma of the Anus. Trials, record NCT01581840. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01581840
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Radiochemotherapy With Panitumumab in the Localised Epidermoid Carcinoma of the Anus
- NCT number
- NCT01581840
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 45 participants, actual
- Lead sponsor
- Federation Francophone de Cancerologie Digestive
- Conditions
- Epidermoid Carcinoma, Anus
- Interventions
- radiochemotherapy, Panitumumab
- First posted
- 2012-04-20
- Last updated
- 2024-07-01
- Results first posted
- 2024-07-01
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Patients With Complete Response to Treatment | 8 weeks evaluations after the end of the treatment by radiochemotherapy | Complete response was defined by the complete disappearance of the tumor on proctological examination and morphological examinations (MRI and/or echo-endoscopy) and the absence of secondary lesion appearance. The responses were validated by an independent committee: * In the event of a discrepancy between the investigator and the independent committee, the independent committee's response was used; * in case of uncertainty of the investigator on the response, the committee decided on the response in view of the clinical and morphological data; This endpoint was assessed 8 weeks after the end of treatment (week 15). A patient who died (regardless of cause) was considered a failure for the primary endpoint |
| Secondary | Percentage of Patients With Complete Response to Treatment | 16 weeks after the end of the treatement by radiotherapy | Complete response was defined by the complete disappearance of the tumor on proctological examination and morphological examinations (MRI and/or echo-endoscopy) and the absence of secondary lesion appearance according to the investigator's opinion |
| Secondary | 3 Years Colostomy-free Survival (CFS) | At 3 years after inclusion | It was defined as the time from inclusion to the date of colostomy or death (from any cause). Patients alive without colostomy were censored at date of last news. If a patient had a shunt colostomy and continuity wasrestored, the patient was counted among the patients without a colostomy. |
| Secondary | Recurrence-free Survival (RFS) at 3 Years | At 3 years after inclusion | It was defined as the time from inclusion to the date of first recurrence (local, regional, metastatic and second anal cancer) or death. Patients alive without recurrence were censored at date of last news. |
| Secondary | Overall Survival (OS) at 12 Months | At 12 months after inclusion | The percentage was evaluated at 12 months using the Kaplan Meier estimation. In the safety part all the death collected during the study will be reported. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Patients With Complete Response to Treatment | 8 weeks evaluations after the end of the treatment by radiochemotherapy | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Percentage of Patients With Complete Response to Treatment | 16 weeks after the end of the treatement by radiotherapy | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | 3 Years Colostomy-free Survival (CFS) | At 3 years after inclusion | % of patients Colostomy-free at 3 years | NUMBER | |
| SECONDARY | Recurrence-free Survival (RFS) at 3 Years | At 3 years after inclusion | % of pts with Reccurence-free at 3 yrs | NUMBER | |
| SECONDARY | Overall Survival (OS) at 12 Months | At 12 months after inclusion | % of patients alive at 12 months | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Patients With Complete Response to Treatment | 5Fu-mitomycine-panitumumab + Radiotherapy | Complete response | 30 | Participants | |
| Percentage of Patients With Complete Response to Treatment | 5Fu-mitomycine-panitumumab + Radiotherapy | Partial response | 10 | Participants | |
| Percentage of Patients With Complete Response to Treatment | 5Fu-mitomycine-panitumumab + Radiotherapy | Stability | 0 | Participants | |
| Percentage of Patients With Complete Response to Treatment | 5Fu-mitomycine-panitumumab + Radiotherapy | Progression | 4 | Participants | |
| Percentage of Patients With Complete Response to Treatment | 5Fu-mitomycine-panitumumab + Radiotherapy | Death before the evaluation | 1 | Participants | |
| Percentage of Patients With Complete Response to Treatment | 5Fu-mitomycine-panitumumab + Radiotherapy | Complete response | 27 | Participants | |
| Percentage of Patients With Complete Response to Treatment | 5Fu-mitomycine-panitumumab + Radiotherapy | Partial response | 9 | Participants | |
| Percentage of Patients With Complete Response to Treatment | 5Fu-mitomycine-panitumumab + Radiotherapy | Stability | 1 | Participants | |
| Percentage of Patients With Complete Response to Treatment | 5Fu-mitomycine-panitumumab + Radiotherapy | Progression | 7 | Participants | |
| 3 Years Colostomy-free Survival (CFS) | 5Fu-mitomycine-panitumumab + Radiotherapy | 68.8 | 95% Confidence Interval 53.1 to 80.2 | % of patients Colostomy-free at 3 years |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 5Fu-mitomycine-panitumumab + Radiotherapy | 45 | |
| Overall Study | COMPLETED | 5Fu-mitomycine-panitumumab + Radiotherapy | 45 | |
| Overall Study | NOT COMPLETED | 5Fu-mitomycine-panitumumab + Radiotherapy | 0 |
Source ClinicalTrials.gov
Adverse events34
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Erythema | Skin and subcutaneous tissue disorders | 5Fu-mitomycine-panitumumab + Radiotherapy | 25 | 45 | |
| other | Prurit | Skin and subcutaneous tissue disorders | 5Fu-mitomycine-panitumumab + Radiotherapy | 12 | 45 | |
| other | Acneiform rash | Skin and subcutaneous tissue disorders | 5Fu-mitomycine-panitumumab + Radiotherapy | 25 | 45 | |
| other | Cutaneous rash | Skin and subcutaneous tissue disorders | 5Fu-mitomycine-panitumumab + Radiotherapy | 11 | 45 | |
| other | Vulvar and vaginal inflammation | Reproductive system and breast disorders | 5Fu-mitomycine-panitumumab + Radiotherapy | 22 | 45 | |
| other | Cystitis | Renal and urinary disorders | 5Fu-mitomycine-panitumumab + Radiotherapy | 19 | 45 | |
| other | Pollakiurie | Renal and urinary disorders | 5Fu-mitomycine-panitumumab + Radiotherapy | 7 | 45 | |
| other | Diarrhea | Gastrointestinal disorders | 5Fu-mitomycine-panitumumab + Radiotherapy | 34 | 45 | |
| other | Abdominal pain | Gastrointestinal disorders | 5Fu-mitomycine-panitumumab + Radiotherapy | 10 | 45 | |
| other | Anal pain | Gastrointestinal disorders | 5Fu-mitomycine-panitumumab + Radiotherapy | 19 | 45 |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 5Fu-mitomycine-panitumumab + Radiotherapy | 10 | 45 |
| Total, other adverse events | 5Fu-mitomycine-panitumumab + Radiotherapy | 45 | 45 |
| Total, serious adverse events | 5Fu-mitomycine-panitumumab + Radiotherapy | 14 | 45 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01581840
GET https://conductscience.org/api/trials/v1/NCT01581840/events?page=2